United States - English - NLM (National Library of Medicine)

h.j. harkins company, inc. - citalopram hydrobromide (unii: i1e9d14f36) (citalopram - unii:0dhu5b8d6v) - citalopram 20 mg - citalopram tablets are indicated for the treatment of depression. the efficacy of citalopram tablets in the treatment of depression was established in 4-6 week, controlled trials of outpatients whose diagnosis corresponded most closely to the dsm-iii and dsm-iii-r category of major depressive disorder (see clinical pharmacology ). a major depressive episode (dsm-iv) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms:  depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. citalopram tablets are contraindicated in patients with a hypersensitivity to citalopram or any of the inactive ingredients in cital

United States - English - NLM (National Library of Medicine)

h.j. harkins company, inc. - flurazepam hydrochloride (unii: 756rdm536m) (flurazepam - unii:ihp475989u) - flurazepam hydrochloride 30 mg - flurazepam hydrochloride capsules are a hypnotic agent useful for the treatment of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakening. flurazepam hydrochloride capsules can be used effectively in patients with recurring insomnia or poor sleeping habits, and in acute or chronic medical situations requiring restful sleep. sleep laboratory studies have objectively determined that flurazepam hydrochloride capsules are effective for at least 28 consecutive nights of drug administration. since insomnia is often transient and intermittent short-term use is usually sufficient. prolonged use of hypnotics is usually not indicated and should only be undertaken concomitantly with appropriate evaluation of the patient. flurazepam hydrochloride capsules are contraindicated in patients with known hypersensitivity to the drug. benzodiazepines may cause fetal damage when administered during pregnancy. an increased risk of congenital malformations associated wi

United States - English - NLM (National Library of Medicine)

h.j. harkins company, inc. - paroxetine hydrochloride (unii: 3i3t11ud2s) (paroxetine - unii:41vrh5220h) - paroxetine 10 mg - paroxetine tablets, usp are indicated for the treatment of major depressive disorder. the efficacy of paroxetine tablets, usp in the treatment of a major depressive episode was established in 6-week controlled trials of outpatients whose diagnoses corresponded most closely to the dsm-iii category of major depressive disorder (see clinical pharmacology —clinical trials). a major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. the effects of paroxetine tablets, usp in hospitalized depressed patients have not been adequately studied. the efficacy

United States - English - NLM (National Library of Medicine)

h. j. harkins company inc. - indomethacin (unii: xxe1cet956) (indomethacin - unii:xxe1cet956) - indomethacin extended-release capsules are indicated for: moderate to severe rheumatoid arthritis including acute flares of chronic disease moderate to severe ankylosing spondylitis moderate to severe osteoarthritis acute painful shoulder (bursitis and/or tendinitis) indomethacin extended-release is contraindicated in the following patients: known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to indomethacin or any components of the drug product [see warnings and precautions (5.7, 5.9)] history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients [see warnings and precautions (5.7, 5.8)] in the setting of coronary artery bypass graft (cabg) surgery [see warnings and precautions (5.1)] 8.1 pregnancy risk summary use of nsaids, including indomethacin extended-release, during the third trimester of pregnancy increases the risk of premature clo

United States - English - NLM (National Library of Medicine)

h.j. harkins company, inc. - buprenorphine hydrochloride (unii: 56w8mw3en1) (buprenorphine - unii:40d3scr4gz) - buprenorphine sublingual tablets are indicated for the treatment of opioid dependence and are preferred for induction. buprenorphine sublingual tablets should be used as part of a complete treatment plan to include counseling and psychosocial support. buprenorphine sublingual tablets is contraindicated in patients with a history of hypersensitivity to buprenorphine, as serious adverse reactions, including anaphylactic shock, have been reported [see warnings and precautions (5.9)]. 8.1 pregnancy risk summary the data on use of buprenorphine, the active ingredient in buprenorphine sublingual tablets, in pregnancy, are limited; however, these data do not indicate an increased risk of major malformations specifically due to buprenorphine exposure. there are limited data from randomized clinical trials in women maintained on buprenorphine that were not designed appropriately to assess the risk of major malformations [see data].observational studies have reported on congenital malformations among buprenorphine-expo

United States - English - NLM (National Library of Medicine)

h.j. harkins company, inc. - ketorolac tromethamine (unii: 4eve5946bq) (ketorolac tromethamine - unii:4eve5946bq) - ketorolac tromethamine 10 mg - carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac tromethamine. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. ketorolac tromethamine tablets are indicated for the short-term (≤ 5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. therapy should always be initiated with iv or im dosing of ketorolac tromethamine, and ketorolac tromethamine tablets are to be used only as continuation treatment, if necessary. the total combined duration of use of ketorolac tromethamine tablets and ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see warnings , precautions , dosage and administration , and adverse reactions ). patients should be switched to alternative analges

United States - English - NLM (National Library of Medicine)

h. j. harkins company inc. - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1) - diclofenac sodium 10 mg - diclofenac sodium topical gel, 1% is indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands. diclofenac sodium topical gel, 1% has not been evaluated for use on the spine, hip, or shoulder. diclofenac sodium topical gel is contraindicated in the following patients: known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product [see warnings and precautions (5.7, 5.9)] history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients [see warnings and precautions (5.7, 5.8)] in the setting of coronary artery bypass graft (cabg) surgery [see warnings and precautions (5.1)] 8.1 pregnancy pregnancy category c prior to 30 weeks gestation; category d starting 30 weeks gestation risk summary use of nsaids, including diclofenac so

United States - English - NLM (National Library of Medicine)

h. j. harkins company inc. - diflunisal (unii: 7c546u4den) (diflunisal - unii:7c546u4den) - carefully consider the potential benefits and risks of diflunisal tablets and other treatment options before deciding to use diflunisal tablets. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings). diflunisal tablets are indicated for acute or long-term use for symptomatic treatment of the following: 1. mild to moderate pain 2. osteoarthritis 3. rheumatoid arthritis diflunisal tablets are contraindicated in patients with known hypersensitivity to diflunisal or the excipients (see description). diflunisal tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other nsaids. severe, rarely fatal, anaphylactic/analphylactoid reactions to nsaids have been reported in such patients (see warnings,anaphylactic/anaphylactoid reactions and precautions, preexisting asthma). diflunisal tablets are contraindicated in the setting of coronary artery bypass

United States - English - NLM (National Library of Medicine)

h.j. harkins company, inc. - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - hydrocodone bitartrate and acetaminophen tablets are indicated for the management of, pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [seewarnings], reserve hydrocodone bitartrate and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] have not been tolerated, or are not expected to be tolerated, have not provided adequate analgesia, or are not expected to provide adequate analgesia hydrocodone bitartrate and acetaminophen tablets are contraindicated in patients with: • significant respiratory depression [see warnings] • acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings] • known or suspected gastrointestinal obstruction, including paralytic ileus [see warnings] • hypersensitivity to hydrocodone or

United States - English - NLM (National Library of Medicine)

h.j. harkins company, inc. - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - hydrocodone bitartrate and acetaminophen tablets are indicated for the management of, pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [seewarnings], reserve hydrocodone bitartrate and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] hydrocodone bitartrate and acetaminophen tablets are contraindicated in patients with: • significant respiratory depression [see warnings] • acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings] • known or suspected gastrointestinal obstruction, including paralytic ileus [see warnings] • hypersensitivity to hydrocodone or acetaminophen (e.g., anaphylaxis) [seewarnings, adverse reactions] controlled substance hydrocodone bitartrate and acetaminophen tablets contains h